Study of EOS884448 Alone, and in Combination With Iberdomide With or Without Dexamethasone, in Participants With Relapsed or Refractory Multiple Myeloma
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 16
- 试验地点
- 13
- 主要终点
- Number of participants with overall response (partial or better) as determined by IMWG criteria
研究概览
简要总结
This is a multicenter, open-label, phase I/II clinical study, to assess the safety, tolerability, antitumor activity, pharmacokinetics and pharmacodynamics of EOS884448 (also known as EOS-448 or GSK4428859A), alone or in combination with iberdomide with and without dexamethasone in participants with relapsed/refractory multiple myeloma (RRMM).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All participants must have a documented diagnosis of relapse/refractory Multiple Myeloma and have measurable disease as defined per IMWG criteria.
- •All participants must have received at least 3 prior lines of MM therapy with IMiD, PI and Anti-CD-38, and progressed on their last therapy (prior BCMA targeted therapy allowed).
- •All participants must have Eastern Cooperative Oncology Group (ECOG) Performance Status of 0,1or
- •All participants must have adequate organ function.
- •Females of childbearing potential (FCBP) or male participant must agree to follow contraception requirements.
排除标准
- •All participants with non-secretory MM
- •All participants with known auto-immune disease
- •All participants with history of life-threatening toxicity related to prior immune therapy.
- •All participants with active graft versus host disease after allogeneic stem cell transplantation.
- •All participants with active, unstable cardiovascular function.
- •All participants with active infection requiring systemic therapy.
- •All participants with hypersensitivity to any of the treatments.
- •All participants with any active gastrointestinal dysfunction that prevents the patient from swallowing tablets or interferes with absorption of study treatment.
研究组 & 干预措施
A: Participants will receive EOS884448
EOS884448 will be administered
干预措施: EOS884448 (Drug)
B: Participants will receive EOS884448 and iberdomide
EOS884448 and iberdomide will be administered
干预措施: EOS884448 (Drug)
B: Participants will receive EOS884448 and iberdomide
EOS884448 and iberdomide will be administered
干预措施: Iberdomide (Drug)
C: Participants will receive EOS884448, iberdomide and dexamethasone
EOS884448, iberdomide and dexamethasone will be administered
干预措施: EOS884448 (Drug)
C: Participants will receive EOS884448, iberdomide and dexamethasone
EOS884448, iberdomide and dexamethasone will be administered
干预措施: Iberdomide (Drug)
C: Participants will receive EOS884448, iberdomide and dexamethasone
EOS884448, iberdomide and dexamethasone will be administered
干预措施: Dexamethasone (Drug)
结局指标
主要结局
Number of participants with overall response (partial or better) as determined by IMWG criteria
时间窗: up to 2 years
Number of participants with any adverse events (AEs) and serious adverse events (SAEs)
时间窗: From first study treatment administration up to 120 days after the last dose
Recommended Phase 2 dose (RP2D) of EOS884448 alone or in combinations with iberdomide with or without dexamethasone in participants with relapse/refractory multiple myeloma
时间窗: up to 2 years
Number of participants with dose limiting toxicity (DLT)
时间窗: From first study treatment administration up to 120 days after the last dose
次要结局
- Time to Response (TTR)(Approximately 48 weeks)
- Maximum concentration (Cmax) of EOS884448 at each dose level(Approximately 48 weeks)
- Duration of Response (DOR)(Until disease progression or death - Approximately 24 months)
- Progression-free-survival (PFS)(Until disease progression or death - Approximately 24 months)
- Percentage of participants with anti-drug antibodies to EOS884448(Approximately 48 weeks)